NRM-823 for advanced or metastatic refractory solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

NRM-823 is being studied in a Phase 1 dose-escalation and expansion format for adults with locally advanced or metastatic refractory solid tumors, focusing on head and neck, esophageal, gastric, and GEJ cancers. Part A uses escalating doses to define safety, tolerability, and a recommended dose, Part B enrolls an expansion cohort at that dose to better characterize safety and early activity, and Part C explores adding a checkpoint inhibitor to the drug to assess combination tolerability. Eligible participants need ECOG 0-1 and adequate organ and marrow function and must meet specified washout periods from prior therapies. The primary objectives are safety and tolerability with exploratory evaluation of anti-tumor signals, conducted at Normunity investigational sites in the United States.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have histologically- or cytologically-diagnosed NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric/GEJ adenocarcinoma, cervical, endometrial, or ovarian cancer which is advanced or metastatic.
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Adequate liver, renal, pulmonary, and cardiac function.
* Adequate hematologic function.

Exclusion Criteria:

* Has received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation therapy) ≤3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NRM-823
* History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from any prior therapy.
* Has received an investigational therapy \<4 weeks or 5 half-lives prior to the first dose of NRM823, whichever is shorter prior to the first dose of NRM-823.
* With the exception of alopecia and Grade ≤2 neuropathy, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study drug.

Where it's running

• Normunity Investigational Site
  Denver, Colorado, United States Recruiting
• Normunity Investigational Site
  New Haven, Connecticut, United States Recruiting
• Normunity Investigational Site
  Washington D.C., District of Columbia, United States Recruiting
• Normunity Investigational Site
  Boston, Massachusetts, United States Recruiting
• Normunity Investigational Site
  Boston, Massachusetts, United States Recruiting
• Normunity Investigational Site
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Judy Schnyder, MBA
• Email: judy.schnyder@normunity.com
• Phone: 215-593-7119

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.